Copeptin in Differentiation of Polyuria and Polydipsia | NCT01056887

Studies
Copeptin in Differentiation of Polyuria and Polydipsia

NCT01056887

Sponsor

University of Wuerzburg

Status

Completed

Last Update Posted

Apr 25, 2011Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Polyuria
Polydipsia

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
33/07

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Nov 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Jan 25, 2010

First Submission Date that Met QC Criteria

Jan 25, 2010

First Posted Date

Jan 26, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2011

Last Update Posted Date

Apr 25, 2011Estimated

Name	Class
Dr. Carson Liu Med Corp.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The differential diagnosis of patients with polyuria/ polydipsia is often complex, but important for the therapeutic strategy.

Challenging is in particular the clinical differentiation between patients with a partial Diabetes insipidus centralis and patients with primary polydipsia as underlying disease, because both groups are associated with similar urinary osmolalities.

The determination of plasma arginine vasopressin is unusual in this context, since measurement of AVP is not reliably.

C-terminal ProVasopressin (copeptin) is secreted stoichiometrically with AVP from the neurohypophysis, but has a longer half life in the circulation, and is thus easier to measure.

Therefore, the investigators will analyze in that study the diagnostic utility of plasma copeptin in the differential diagnosis of polyuria and polydipsia.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Label	Type	Description	Intervention Names
Primary Polydip, D. insipidus

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with polydipsia/ polyuria, with indication for performing a deprivation test
> 18 years

Exclusion Criteria:

dDAVP during the last 14d
pregnancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy probands Patients with diabetes insipdus centralis totalis/ partials Patients with diabetes insipidus renalis Patients with primary polydipsia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Univ Hospital Wuerzburg		Würzburg	Bavaria	97080	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21367924	Derived	Fenske W, Quinkler M, Lorenz D, Zopf K, Haagen U, Papassotiriou J, Pfeiffer AF, Fassnacht M, Stork S, Allolio B. Copeptin in the differential diagnosis of the polydipsia-polyuria syndrome--revisiting the direct and indirect water deprivation tests. J Clin Endocrinol Metab. 2011 May;96(5):1506-15. doi: 10.1210/jc.2010-2345. Epub 2011 Mar 2.

ID	Term
D011141	Polyuria
D059606	Polydipsia
D003919	Diabetes Insipidus
D059607	Polydipsia, Psychogenic

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications